The Spatiotemporal Gait Parameters in LDH Patient

Preoperative and Postoperative Spatiotemporal Gait Parameters and Gait Asymmetry in Patients With Lumbar Disc Herniation: a Prospective, Cross-sectional Study

The aim of this study was to assessment on the interaction of spatial and temporal gait parameters and gait asymmetry in patients with Lumbar Disc Herniation (LDH) before and 15 days after surgery.

Study Overview

• Status: Completed
• Conditions: Pain; Lumbar Disc Herniation
• Intervention / Treatment: Other: All of the spatial and Temporal Gait parameters

Detailed Description

The participants were divided into LDH and healthy control groups. The analysis of the spatiotemporal gait parameters was performed using the "Win-Track" gait analysis platform system for two groups. In addition, the analysis of spatiotemporal gait parameters of 60 participants who had the planned lumbar discectomy surgery, was tested before and 15 days after surgery. The pain intensity of the patients was recorded by the Visual Analog Scale (VAS) immediately before performing the analysis. After then participants completed ten passes on the "Win-Track" Gait Analysis Platform at their self-selected walking speed. The arithmetic mean of the three flawless walking data was used for analysis. The gait symmetry index was used to calculate the walking asymmetry.

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals who were diagnosed with LDH by a specialist;
• Patients had a medical history and proven by MRI with more or less evidence of degenerative lumbar disc;
• Aged between 25-80 years old;
• Pain symptom on the lumbal area or lower extremity.

Exclusion Criteria:

• Patients who have previously received surgery or physical therapy treatment;
• Having congenital deformity in the spine or lower extremity;
• History of spinal surgery or other diseases affecting gait;
• Pregnancy;
• Situations that may cause gait balance problems;
• Using assistive gait appliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lumbar Disc Hernaition Group; The number of participants in this group is anticipated to be 153. The pain intensity of the patients was recorded by a Visual Analog Scale (VAS) immediately before performing the analysis. The patients were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day.	Other: All of the spatial and Temporal Gait parameters
Active Comparator: Healthy Control Group; The number of participants in this group is anticipated to be 54. The participants were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day.	Other: All of the spatial and Temporal Gait parameters
Active Comparator: Preoperative and Postoperative Group; The number of participants in this group is anticipated to be 59. The patients were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day, before and 15 days after surgery.	Other: All of the spatial and Temporal Gait parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Pain intensity was obtained using a Visual Analog Scale (VAS). VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "pain as bad as it could be" or the "worst imaginable pain" (Score of 100 [100-mm scale]) on the right side. The patient was asked to mark the line point that represented his or her current pain.	The pain intensity of the patients was recorded immediately before performing the analysis.
Step length (cm)	Step length is the distance between the heel contact point of one foot and that of the other foot. The step length (cm) was recorded separately for both extremities.	Changes from the step length at 2 weeks
Gait cycle length (cm)	Gait cycle length is the distance between successive foot contacts of the same limbs. The gait cycle length (cm) was recorded separately for both extremities.	Changes from the gait cycle length at 2 weeks
Cadence (step/min)	Cadence is the number of steps per minute.	Changes from the cadence at 2 weeks
Velocity (cm/s)	Velocity is the distance covered in a given period.	Changes from the velocity at 2 weeks
Gait cycle duration (seconds)	Gait cycle duration is the time between successive foot contacts of the same limbs. The gait cycle duration (seconds) was recorded separately for both extremities.	Changes from the gait cycle duration at 2 weeks
Step duration (seconds)	Step duration is the time between two consecutive heel strikes. The step duration (seconds) was recorded separately for both extremities.	Changes from the step duration at 2 weeks
Double stance duration (seconds)	Double stance duration is the time over which the body is supported by both legs. The double stance duration (seconds) was recorded separately for both extremities.	Changes from the double stance duration at 2 weeks
Swing duration (seconds)	Swing duration is the time taken for the leg to swing through while the body is in single support on the other leg. The swing duration (seconds) was recorded separately for both extremities.	Changes from the swing duration at 2 weeks
Gait symmetry	Gait symmetry is a coordinated and consistent activity of locomotion between left and right limb during walking.	Changes from the gait asymmetry at 2 weeks (preoperative and postoperative).

Collaborators and Investigators

• Sponsor: Marmara University
• Collaborators: Bahçeşehir University

Publications and helpful links

General Publications

• Toosizadeh N, Yen TC, Howe C, Dohm M, Mohler J, Najafi B. Gait behaviors as an objective surgical outcome in low back disorders: A systematic review. Clin Biomech (Bristol, Avon). 2015 Jul;30(6):528-36. doi: 10.1016/j.clinbiomech.2015.04.005. Epub 2015 Apr 17.
• Loske S, Nuesch C, Byrnes KS, Fiebig O, Scharen S, Mundermann A, Netzer C. Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis. Spine J. 2018 Dec;18(12):2195-2204. doi: 10.1016/j.spinee.2018.04.016. Epub 2018 Apr 27.

Helpful Links

• Gait behaviors as an objective surgical outcome in low back disorders: A systematic review.
• Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): December 29, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Gait analysis; Spatiotemporal gait parameters; Lumbar Disc Herniation; Gait asymmetry
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: Bahcesehir University (Other Identifier: Bahcesehir University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No